Earlier today, FDA issued a Federal Registernotice notifying holders of applications for certain prescription drug products approved under FDC Act § 505(b) (NDA) or § 505(j) (ANDA) and biological products licensed under § 351 of the Public Health Service Act that they will be deemed to have in effect an approved Risk Evaluation and Mitigation Strategy (“REMS”) under the recently-enacted FDA Amendments Act (“FDAAA”).FDA also made available a “Questions and Answers” document explaining the Federal Register notice and discussing, among other things, when a decision will be made for a specific application that a REMS is needed.

FDAAA was signed into law on September 27, 2007.Title IX, Subtitle A of FDAAA created new FDC Act § 505-1, which authorizes FDA to require applicants submitting a marketing application for a prescription drug or biological product to submit and implement a REMS if the Agency determines that such a mechanism is necessary to ensure that the benefits of the product outweigh its risks.Certain products approved prior to the effective date of FDAAA are, under FDAAA § 909(b)(1), deemed to have a REMS in effect “if there are in effect on the effective date of this Act elements to assure safe use — (A) required under [FDA’s accelerated approval restricted distribution regulations at 21 C.F.R. § 314.520 or § 601.42]; or (B) otherwise agreed to by the applicant and the Secretary [of Health and Human Services] for such drug.”New FDC Act § 505-1(f)(3) states that “elements to ensure safe use” include the following:

(A) health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);

(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area);

(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;

(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;

(E) each patient using the drug be subject to certain monitoring; or

(F) each patient using the drug be enrolled in a registry.

FDAAA § 909 took effect earlier this week, on March 25, 2008.Under FDAAA § 909(b)(3) and today’s Federal Register notice, sponsors of products with “deemed REMS” applications must submit a proposed REMS to FDA by September 21, 2008.“Such proposed strategy is subject to [FDC Act § 505-1] as if included in such application at the time of submission of the application to the Secretary.”

FDA’s Federal Register notice identifies 16 products (subject to 28 approved or licensed applications) approved prior to the effective date of FDAAA Title IX with “elements to assure safe use.”According to FDA’s notice, “[a] drug will not be deemed to have a REMS if it has only a Medication Guide, patient package insert, and/or communication plan.” However, the Agency also states in its “Questions and Answers” document that “[i]n the future, a product with only a new or revised Medication Guide (without elements to assure safe use) will be under a REMS that will include a timetable for assessment of the REMS.”The Agency requests that members of the public notify FDA if they are aware of products that should have a “deemed REMS” in effect, and also requests that application holders who do not believe their product should be on the list submit a letter to the Agency with justification as to why its product was improperly listed.

FDA is reportedly working on an interim guidance document that will describe the content and format of a proposed REMS and provide a template and a model REMS.Violations of REMS are subject to stiff civil monetary penalties.Under FDAAA, the penalties may not exceed $250,000 per violation, or $1 million for all violations adjudicated in a single proceeding.

Also earlier today, Dr. Douglas C. Throckmorton, Deputy Director of FDA’s Center for Drug Evaluation and Research, commented during a presentation concerning FDAAA implementation at the Food and Drug Law Institute’s Annual Conference here in Washington, D.C. that FDA will use its REMS authority “judiciously,” as there is a “targeted use” per FDAAA.“Too many [REMS] would increase confusion in the system, [and] could increase errors and decrease [product] availability,” according to Dr. Throckmorton.